(99 days)
Not Found
No
The device description focuses on physical components and mechanical function, with no mention of AI/ML algorithms or data processing for decision-making or analysis.
Yes
The device is used for breast reconstruction following mastectomy and treatment of underdeveloped breasts and soft tissue deformities, which are medical treatments or corrections.
No
The device is a tissue expander used for breast reconstruction and treatment of soft tissue deformities. It is an implantable device designed for physical expansion, not for diagnosing medical conditions.
No
The device description clearly details a physical implantable device made of silicone elastomer with various hardware components like suture tabs, an injection site, and magnets. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description and Intended Use: The NATRELLE® Tissue Expanders are described as devices for temporary subcutaneous implantation in the body for breast reconstruction and treatment of soft tissue deformities. They are physically implanted into the patient.
The device's function is to physically expand tissue within the body, not to analyze samples taken from the body. Therefore, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NATRELLE® Tissue Expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expanders are intended for temporary subcutaneous implantation and are not intended for use beyond six months.
Product codes
LCJ
Device Description
Allergan's Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, three suture tabs, a MAGNA-SITE® integrated injection site (incorporating a titanium needle guard), and a stable, reinforced base to enable outward expansion. The three suture tabs are attached to the posterior surface of the shell at approximately the 12 o'clock, 4 o'clock, and 8 o'clock positions of the tissue expander. The Tissue Expanders are available in seven styles and each style consists of six sizes for a total of 42 products, to meet diverse surgical needs.
The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. All injection sites contain a self-sealing port and a titanium needle guard to prevent inadvertent puncture through the base of the injection site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Suture tab bond integrity was tested in accordance with ISO 14607:2007(E), ASTM F1441 and Allergan’s internal standards and procedure, and predetermined acceptance criteria were met.
The device passed all preclinical testing, indicating that no new questions of safety and effectiveness are introduced with the proposed modification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NATRELLE® Style 133 Series Tissue Expander Matrix (K862203)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K102806
page 1/2
510(k) SUMMARY
JAN
| JAN 5 2011 | |||
|---|---|---|---|
| 510(k) Owner: | Allergan Medical | ||
| Contact: | Micah Schloss | ||
| Phone: | 805-961-5828 | ||
| Fax: | 714-796-9724 | ||
| Date Summary Prepared: | September 27, 2010 | ||
| Device: | |||
| Trade Name: | NATRELLE® 133 Tissue Expander with Suture Tabs | ||
| Common/Classification Name: | Expander, Skin, Inflatable | ||
| Classification Regulation: | LCJ (Unclassified) | ||
| Predicate Devices: | NATRELLE® Style 133 Series Tissue Expander Matrix (K862203) | ||
| Device Description: | Allergan's Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, three suture tabs, a MAGNA-SITE® integrated injection site (incorporating a titanium needle guard), and a stable, reinforced base to enable outward expansion. The three suture tabs are attached to the posterior surface of the shell at approximately the 12 o'clock, 4 o'clock, and 8 o'clock positions of the tissue expander. The Tissue Expanders are available in seven styles and each style consists of six sizes for a total of 42 products, to meet diverse surgical needs. | ||
| The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. All injection sites contain a self-sealing port and a titanium needle guard to prevent inadvertent puncture through the base of the injection site. | |||
| Intended Use: | The NATRELLE® Tissue Expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expanders are intended for temporary subcutaneous implantation and are not intended for use beyond six months. |
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K102806 page 2/2
Allergan Medical
Special 510(k): Device Modification NATRELLE® 133 Tissue Expanders with Suture Tabs
The predicate device and the modified device utilize the same fundamental Technological Characteristics: technology:
- · A silicone expansion envelope with a BIOCELL® textured surface, which expands with sequential injections of sterile saline
- · A silicone injection site, with self-sealing port, a magnetic locating system and a titanium needle guard
In accordance with ISO 10993-1:2009 and Allergan's internal standards and Biocompatibility procedures, a biocompatibility review of Mohawk P118 polyester mesh was Data: performed. Based on the test results, the material is approved and considered qualified for use in the suture tabs of NATRELLE® Tissue Expanders. All other materials used in NATRELLE® Tissue Expanders are identical to those used in the predicate device.
Suture tab bond integrity was tested in accordance with ISO 14607:2007(E), Performance ASTM F1441 and Allergan's internal standards and procedure, and Testing: predetermined acceptance criteria were met.
The device passed all preclinical testing, indicating that no new questions of Conclusions: safety and effectiveness are introduced with the proposed modification. NATRELLE® 133 Tissue Expander with Suture Tabs is substantially equivalent to Allergan's currently marketed NATRELLE® Style 133 Series Tissue Expander Matrix (K862203).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
3 - 11
the state of the state of the states of the states of
Allergan Medical % Mr. Micah Schloss Associate Regulatory Analyst 71 S. Los Carneros Road Goleta, California 93117-5506
Re: K102806
Trade/Device Name: NATRELLE® Tissue Expanders Regulation Number: 21 CFR 878.3600 Regulation Name: Tissue expander Regulatory Class: II Product Code: LCJ Dated: December 3, 2010 Received: December 8, 2010
Dear Mr. Schloss:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Micah Schloss
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, pease note the regulation entitled, "Misbranding by reference to premarket notification" (21 CIFR Preu 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Arij. Vs. Nh
fr.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Allergan Medical
Special 510(k): Device Modification NATRELLE® 133 Tissue Expanders with Suture Tabs
Indications for Use
510(k) Number (if known):
Device Name:
NATRELLE® Tissue Expanders
Indications for Use:
The NATRELLE® Tissue Expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expanders are intended for temporary subcutaneous implantation and are not intended for use beyond six months.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Daniel Krone for MXM | |
|---|---|
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K102806 |